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NF EN 12442-1:2000被替代

Animal Tissues And Their Derivatives Utilized In The Manufacture Of Medical Devices - Part 1: Analysis And Management Of Risk

出版:Association Francaise de Normalisation

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基本信息
标准编号: NF EN 12442-1:2000
发布时间:2000/12/1 0:00:00
标准类别:Standard
出版单位:Association Francaise de Normalisation
标准页数:20
标准简介

Applicable to medical devices (excluding in-vitro diagnostic medical devices) made using animal tissue or products derived from animal tissue which are or have been rendered non-viable. Specifies a procedure to investigate, using available information the safety of such devices by identifying hazards and estimating risks associated with the device (risk analysis).

标准备注

Indice de classement: S97-601-1 Supersedes NFS 97 601-1 (03/2004)

替代本标准的新标准

NF EN ISO 22442-1:2008

等同采用的国际标准

NEN EN 12442-1:2000 - Identical

SS EN 12442-1 Ed. 1 (2001) - Identical

UNE EN 12442-1:2001 - Identical

NS EN 12442-1 Ed. 1 (2000) - Identical

I.S. EN 12442-1:2000 - Identical

UNI EN 12442-1:2002 - Identical

NBN EN 12442-1:2000 - Identical

ONORM EN 12442-1:2000 - Identical

DIN EN 12442-1 (2001-01) - Identical

BS EN 12442-1:2000 - Identical

SN EN 12442-1:2000 - Identical